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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021074
Company: 3M

Products on NDA 021074

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AVAGARD	ALCOHOL; CHLORHEXIDINE GLUCONATE	61%;1%	SOLUTION;TOPICAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021074

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/07/2001	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-074_Avagard_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21074ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-074_Avagard.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/06/2017	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021074Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021074Orig1s012ltr.pdf
11/04/2016	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021074Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021074Orig1s011ltr.pdf
11/12/2015	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021074Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021074Orig1s010ltr.pdf
02/15/2013	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/21074Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021074Orig1s009ltr.pdf
06/07/2012	SUPPL-8	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021074s008ltr.pdf
05/17/2012	SUPPL-7	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021074s007ltr.pdf
07/23/2002	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 021074

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/06/2017	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021074Orig1s012lbl.pdf
11/04/2016	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021074Orig1s011lbl.pdf
11/12/2015	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021074Orig1s010lbl.pdf
02/15/2013	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/21074Orig1s009lbl.pdf
06/07/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-074_Avagard_Prntlbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

AVAGARD

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SOLUTION;TOPICAL; 61%;1%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
AVAGARD	ALCOHOL; CHLORHEXIDINE GLUCONATE	61%;1%	SOLUTION;TOPICAL	Over-the-counter	Yes	021074	3M

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